Quality Assurance Executive

Kilitch Drugs; Khopoli; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Kilitch Drugs is seeking a QA professional to ensure cGMP and WHO-GMP compliance, review BMR/BPR, and release finished products. The role involves managing QMS activities including deviations, OOS, CAPA and change control, and coordinating with production, QC, and other departments.

The candidate will oversee validation and qualification activities for processes and equipment, drive continuous quality improvements, and handle regulatory, customer, and internal audits across the site in Khopoli,

Qualifications

• Ensure proper documentation and SOP compliance.
• Coordinate with Production, QC, and other departments.
• Drive continuous quality improvement initiatives.
• Handle regulatory, customer, and internal audits.

Responsibilities

• Ensure compliance with cGMP, WHO-GMP & regulatory requirements.
• Review & approve BMR/BPR & release of finished products.
• Manage QMS activities Deviation,OOS,CAPA, Change Control.
• Oversee validation & qualification activities (process, leaning,equipment)

Skills

cGMP

Regulatory compliance

Documentation

SOP compliance

Audit coordination

QMS management

Tools

BMR/BPR

Job description

• Ensure compliance with cGMP, WHO-GMP & regulatory requirements
• Review & approve BMR/BPR & release of finished products
• Manage QMS activities Deviation,OOS,CAPA, Change Control
• Oversee validation & qualification activities (process, leaning,equipment)

Required Candidate profile

• Ensure proper documentation and SOP compliance
• Coordinate with Production, QC, and other departments
• Drive continuous quality improvement initiatives
• Handle regulatory, customer, and internal audits